MAUDE Adverse Event Report: SAMSUNG MEDISON CO., LTD. RS80A DIAGNOSTIC ULTRASOUND SYSTEM; DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES

Model Number	RS80A
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Codes	No Information (3190); Missing Value Reason (3192)
Date of Event	01/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A software patch is in development to display the correct highest value.This error only occurs when the the blood flow velocity of reverse direction is measured with the setting value changed from "proximal" to "highest" in the ica / cca ratio option as the default value.The user can recognize whether the highest value is erroneous through the report in which the detailed measurement value is described.The software patch v3.00.05 will resolve this issue and address the concern with the absolute value used in the algorithm.There was no harm to the patient as a result of this issue.
Event or Problem Description
Software issue detected by applications specialist on a rs80a prestige system running software version 3.00.03.When the blood flow velocity of reverse direction is measured with the setting value changed from "proximal" to "highest" in the ica / cca ratio option as the default value, non-highest value is displayed as "highest psv/edv".The issue pertains to carotid exams where the rs80a software is not displaying the absolute value.

• Brand Name: RS80A DIAGNOSTIC ULTRASOUND SYSTEM
• Common Device Name: DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES
• Manufacturer (Section D): SAMSUNG MEDISON CO., LTD.; 3366, hanseo-ro, nam-myeon; hongcheon-gun gangweondo 250-8 74; KS 250-874
• MDR Report Key: 6354949
• Report Number: 3004938766-2017-00003
• Device Sequence Number: 13597814
• Product Code: IYN
• UDI-Device Identifier: 08806167760045
• UDI-Public: 08806167760045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2017
• Report Date (Section F): 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: RS80A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/24/2017
• Device Age: 1 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/14/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/23/2017